A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older


Clinical Trial

Offered by: Nemours
Location: Orlando, Fla. and Pensacola, Fla.

What is the trial about?

The purpose of the study is to find out if the Podhaler device is easy to use and if the instructions are easy to understand and follow. No medication is given, but placebo powder, which will be provided in capsules for inhalation (breathing in).

Who can participate?

6 years of age or older and has Cystic Fibrosis.

What is involved?

  • You (and/or your child) will be asked to complete a short reading test to see how well you (and/or your child) can read.
  • You (or your child) will be given the package of the TOBI Podhaler (device and capsules with placebo powder) and will be asked to read the Instructions for the TOBI Podhaler. Children up to 10 years of age will get help from their caregivers; children older than 10 years will get the level of help from their caregivers they would normally receive when using a new medication the first time.
  • Your child will be asked to inhale a full dose of placebo powder using the TOBI Podhaler device. If your child is not sure about what he/she has to do, you (or your child) can also go back to the instructions and read any part of them again, as often as you (or your child) want.
  • Afterwards you (and/or your child) will be asked some questions about the TOBI Podhaler and what you have understood from the instructions (interview). The questions you will be asked are not to test you (or your child), but to see if the TOBI Podhaler was easy or difficult to use and whether the explanations in the instructions are easy to understand and follow.
  • While you (or your child) read the instructions and use the TOBI Podhaler, you (or your child) will be video recorded and study personnel will write down what you (or your child) are doing. The interview portion of the visit will also be video recorded.
  • Participation will last for approximately 2-3 hours during a single visit.

Your child’s Study Doctor will do a physical examination of your child including measurement of your child’s height, weight, blood pressure and heart rate. If your child is female of child bearing age, your child’s urine will be tested to see if your child is pregnant. The results of breathing tests your child had done in the past year will be used to check if your child qualifies for the study. During the study “treatment period”, your child will receive placebo powder in capsules (does not contain any active medicine). Your child will be asked to inhale one full dose using the TOBI Podhaler.

Contact Nemours Clinical Trials

Trial Name: A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org